Clinical trial · Interventional
Impact of Robotic Versus Endoscopic Surgery on Nipple Nerve Function Following Nipple-Sparing Mastectomy for Breast Cancer
A Multicenter, Prospective, Randomized Two-arm Controlled Trial Comparing the Impact of Robotic Versus Endoscopic Surgery on Breast Nerve Function Following Nipple-sparing Mastectomy for Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Oct 1, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20261001-000001
Summary
Brief summary (as posted)
This is a multicenter, prospective, randomized parallel controlled two arm clinical trial, designed to systematically evaluate impact of robotic versus endoscopic surgery on breast nerve function in patients undergoing nipple sparing mastectomy for breast cancer. The study will comprehensively assess the neurological functional outcomes, oncological safety, quality of life and sexual health, perioperative efficacy, surgical complications, and health economic value of the two minimally invasive approaches. This study has been approved by the Institutional Review Board of the Affiliated Women and Children's Medical Center of Guangzhou Medical University. Written informed consent will be obtained from all eligible participants prior to enrollment. All patient data will be anonymized and kept strictly confidential. Statistical analyses will be performed using SPSS 27.0 software, with a P value \< 0.05 set as the threshold for statistical significance.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic-assisted nipple-sparing mastectomy | Procedure | — | UNRESOLVED |
| Robotic-assisted nipple-sparing mastectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Robotic-assisted nipple-sparing mastectomy group
- description
- Patients undergo robotic-assisted nipple-sparing mastectomy for breast cancer.
- interventionNames
- Procedure: Robotic-assisted nipple-sparing mastectomy
- type
- EXPERIMENTAL
- label
- Endoscopic-assisted nipple-sparing subcutaneous mastectomy group
- description
- Patients undergo endoscopic-assisted nipple-sparing mastectomy for breast cancer.
- interventionNames
- Procedure: Endoscopic-assisted nipple-sparing mastectomy
Primary outcomes (2)
- measure
- Tactile pressure sensation of the nipple-areola complex at 6 months postoperatively
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Ductal carcinoma in situ (DCIS), or invasive breast cancer with clinical stage T1-T3, N0-N1 and no distant metastasis; 2. Breast size ≤ cup C, without significant breast ptosis; 3. Patients with high aesthetic requirements who elect single-incision robotic or endoscopic-assisted nipple-sparing mastectomy; 4. Patients eligible for prophylactic mastectomy; 5. Patients understand the study protocol and sign the written informed consent form. Exclusion Criteria: 1. Tumor invasion of the nipple-areola complex, skin, or chest wall; 2. Inflammatory breast cancer; 3. Patients with poor general condition who are unable to tolerate surgery.
References
Publications (0)
Data not yet available